Real-Time Cleanroom Particle Counting & Monitoring
In a controlled environment, what you can’t see can hurt you. Microscopic airborne particulates – dust, microbes, and aerosol fibers – are the primary threat to product yield and safety in semiconductor, pharmaceutical, and medical device manufacturing.
Our automated particle counting solutions provide the continuous, high-fidelity data required to maintain ISO 14644-1 classifications and ensure your facility remains in a constant state of control.
The Evolution of Contamination Control
Handheld spot checks only provide a “snapshot” of air quality. True compliance requires a proactive, continuous strategy. Our system transforms particle counting from a manual chore into a real-time defense mechanism.
- ISO Class 1–9 Compliance: Accurately measure particles ranging from 0.1 µm to 5.0 µm to meet specific cleanroom grade requirements.
- Non-Viable & Viable Detection: Differentiate between inert dust and potentially hazardous microbiological constituents.
- Immediate Source Identification: Use real-time data spikes to pinpoint exactly when and where contamination enters your environment (e.g., during gowning, equipment operation, or cleaning).
- Energy Optimization: Leverage particle data to implement “Demand-Controlled Filtration,” reducing HVAC fan speeds when the room is at rest to save significantly on utility costs.
Professional-Grade Particle Sensing Technology
| Feature | Specification / Benefit |
|---|---|
| Laser Diode Technology | High-reliability light scattering sensors for precise particle sizing and counting. |
| Isokinetic Sampling | Specialized probes that ensure air enters the sensor at the same velocity as the room airflow for accurate results. |
| Built-in Flow Sensors | Automatically detects and alerts you to any drop in sampling flow rate, ensuring data integrity. |
| 21 CFR Part 11 Software | Secure, unalterable data logs with electronic signatures and full audit trails for FDA/GMP audits. |
| Remote & Portable Options | Fixed sensors for continuous monitoring or portable units for cleanroom validation and troubleshooting. |
Regulatory Compliance & Standards
Our systems are engineered to help you satisfy the world’s most demanding regulatory bodies:
- ISO 14644-1 & -2: The “Gold Standard” for cleanroom classification and monitoring frequency.
- EU GMP Annex 1: Stringent requirements for continuous monitoring in Grade A and B zones.
- FDA 21 CFR Part 11: Ensures your digital records are trustworthy and ready for inspection.
- USP <797>: Vital for sterile compounding pharmacies monitoring non-viable particulates.
Why Choose Remote Over Manual Counting?
While handheld units are excellent for periodic validation, Remote Particle Counters (RPCs) offer the only path to a fully automated facility:
- Reduce Personnel Interference: Minimizing the presence of technicians for manual counts reduces the single largest source of cleanroom contamination: humans.
- Contemporaneous Documentation: Data is logged exactly when it happens, creating a seamless compliance history without manual data entry.
- Visual Status Lights: Integrated LEDs at each sensor provide a “Green/Yellow/Red” status for immediate feedback to cleanroom operators.
Expert Insight: The new EU GMP Annex 1 guidelines emphasize the “risk-based” placement of particle counters. Our team can help you identify your “worst-case” sampling locations to ensure your monitoring plan is bulletproof.
